Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
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Purpose
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls.
Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
| Condition | Intervention |
|---|---|
|
Asthma Vitamin D Resistant Rickets |
Other: Methacholine Challenge Test |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients |
- Metacholine Challenge Test [ Time Frame: baseline ] [ Designated as safety issue: Yes ]As assessed by methacholine challenge test with determination of PC20.
- IgE [ Time Frame: baseline ] [ Designated as safety issue: No ]in peripheral Blood count
- CBC [ Time Frame: baseline ] [ Designated as safety issue: No ]in peripheral Blood count
- Fractional Exhaled NO [ Time Frame: baseline ] [ Designated as safety issue: No ]determination of exhaled NO in Exhaled breath
- skin tests for inhaled allergens [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Inhaled breath condensate [ Time Frame: baseline ] [ Designated as safety issue: No ]
- C reactive protein [ Time Frame: baseline ] [ Designated as safety issue: No ]in peripheral Blood count
- 25 OH vitamin D3 [ Time Frame: baseline ] [ Designated as safety issue: No ]in peripheral Blood count
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Healthy Control |
Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test
|
|
Active Comparator: Vitamin D resistant Rickets
Vitamin D resistant Rickets patients
|
Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test
|
Detailed Description:
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.
Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D.
Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate.
Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls.
Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test.
Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.
Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
Eligibility| Ages Eligible for Study: | 3 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Vitamin D Resistent Rickets
- Age between 3 - 40 years
Exclusion Criteria:
- Any Chronic Lung Disease
- Febrile Illness in last 2 weeks
- Inhaled Corticosteroids over the past 2 weeks
- Bronchodilators over the past 24 hours
- Participation in any other clinical studies over the past 4 weeks
Contacts and Locations More Information
No publications provided
| Responsible Party: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01578824 History of Changes |
| Other Study ID Numbers: | Vit D and asthma in VDRR CTIL |
| Study First Received: | November 9, 2011 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rambam Health Care Campus:
|
Rickets Vitamin D airway hyperreactivity Exhaled breath condensate |
Additional relevant MeSH terms:
|
Asthma Rickets Hypophosphatemic Rickets, X-Linked Dominant Phosphorus Metabolism Disorders Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hypophosphatemia, Familial Renal Tubular Transport, Inborn Errors Kidney Diseases Urologic Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Metal Metabolism, Inborn Errors Metabolism, Inborn Errors |
ClinicalTrials.gov processed this record on May 21, 2013